Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation.
研究概览
简要总结
This is a multi-site, randomized, investigator-initiated pilot study to evaluate the efficacy of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of radio opaque contrast used during a cryoballoon pulmonary vein isolation procedure for atrial fibrillation.
One group of subjects will have the procedure performed with intracardiac echo maneuvers to assess cryoballoon occlusion of the pulmonary vein and will be compared to a group of subjects who will receive the standard medical treatment with fluoroscopy and angiography.
详细描述
Surgical and catheter based technologies target triggers that initiate atrial fibrillation located in the pulmonary veins (PV). In order to isolate these triggers, radiofrequency energy or freezing is used to destroy the atrial tissue which propagate electrical impulses into and out of the pulmonary veins (PV), to achieve pulmonary vein isolation (PVI). Use of a patented cryoballoon catheter (Medtronic) to perform PVI has been shown to be safe and efficacious under fluoroscopic guidance with contrast angiography. The objective of this study is to identify methods to reduce radiation dose and radio opaque contrast use while maintaining PVI efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Subjects will be randomized in a 2:1 fashion
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal atrial fibrillation refractory to treatment with anti-arrhythmic drugs
- •Must be able to undergo pre-operative cardiac CT angiogram or cardiac MRI to define pulmonary vein anatomy.
- •Exclusion criteria:
- •Planned use of radiofrequency cardiac ablation
- •Presence of a cardiac implantable electronic device
- •Conditions where manipulation of the catheter would be unsafe such as intracardiac thrombus
- •Patients with active systemic infections
- •Patients with cryoglobulinemia
- •Pregnant and/or breast-feeding females are excluded from this study.
排除标准
- 未提供
研究组 & 干预措施
Non-fluoroscopic Cryoballoon PVI
- Observation of pressure waveform change at the tip of the cryoballoon catheter from left atrial pressure to pulmonary vein pressure waveform.
- Intracardiac echocardiography (ICE) imaging with no Doppler color evidence of peri-balloon high velocity leaks.
- Intracardiac echo imaging showing no evidence of leak during agitated saline contrast injection into cryoballoon catheter positioned at pulmonary vein ostium.
干预措施: Cryoballoon Pulmonary Vein Isolation - PVI (Procedure)
Fluoroscopic Cryoballoon PVI
Standard cryoballoon PVI using radio opaque contrast pulmonary vein angiography
干预措施: Cryoballoon Pulmonary Vein Isolation - PVI (Procedure)
结局指标
主要结局
Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation.
时间窗: one year
change in the composite endpoint of total fluoroscopy time (min)
Reduction of Contrast during Cryoballoon Pulmonary Vein Isolation.
时间窗: one year
change in the composite endpoint of contrast (cc)
次要结局
- Time to Cryoballoon Pulmonary Vein Isolation(one year)
- Recurrence of atrial fibrillation(one year)
研究者
Richard Wu
Professor of Internal Medicine
University of Texas Southwestern Medical Center